Evelien Van Den Brink and I were interested in what clinical trials are currently planned or ongoing for ME/CFS. It can take many years to conduct a clinical trial and report the results, so we wanted to know what we can expect to come out in the next years.
A search of databases that register clinical trials
We did a quick search of the main databases where researchers are supposed to register their clinical trials. We were mainly interested in randomized controlled trials that have the intention to test the efficacy of a treatment and less interested in phase I studies (that focus on safety testing) or open-label studies (that have no control group).
Unfortunately, the WHO International Clinical Trials Registry Platform (ITCRP) website was not functioning, due to heavy traffic generated by the COVID-19 outbreak. We did manage to search the other main databases that are the main data suppliers for the WHO, namely: Clinicaltrials.gov, ISRCTN, ANZCTR, DRKS, EudraCT, and NTR. We also had a look at the main charities that fund ME/CFS research to see if they had plans for clinical trials. The results of our search are summarized in this Google document (which should be open for all to see and comment on). If you know of any (randomized controlled) trials for ME/CFS that aren’t listed in this document, feel free to make a comment or let me know through social media.
Few drug trials, several on fecal microbiota transplantation
We found approximately 30 trials, which can be grouped into different categories. First off are drug trials, but unfortunately, there are very few of these. The one by Jarred Younger on Naltrexone is currently suspended. There is also one on Mestinon by David Systrom. That’s about it. The Open Medicine Foundation recently announced a study in Sweden that will test Kynurenine, but this hasn’t been registered yet.
Other preliminary reports such as the ones on CT38 (the drug developed by Cortene) and cyclophosphamide (which was trialed by the Norwegian research team of Mella and Fluge) have raised hope that larger trials will follow. But thus far we couldn’t find plans, protocols, or registration of further studies to test the efficacy of these treatments.
A whole lot of shit
Secondly, there are a couple of trials into fecal microbiota transplantation (FMT) where doctors take the stool of a healthy donor and insert it into a ME/CFS patient, hoping that it will restore the gut flora and help alleviate symptoms. The comeback study in Norway will test this procedure in 80 patients, but there is also a registered Finnish study and one supported by Invest in ME at the Quadram Institute that hope to test FMT in ME/CFS.
Supplements, Chinese remedies, and behavioral interventions
There are more trials in the third category, namely those that will test supplements. The most prominent one is the one by Dikoma Shungu on N-acetylcysteine. Others plan to test a mixture of supplements that have names such as RiaGev™, ReConnect®, Gutmagnific, or ImmunoVit. In our view, many of these trials are not so much a sign of hope but an indication that the ME/CFS research community hasn’t reached the level of professionalism that patients deserve.
The same can be said about the handful of studies that will test ancient Chinese remedies, such as acupuncture, tao yin exercises, moxibustion, and Sijunzi decoction. It is doubtful that the investigators of these trials really know what ME/CFS entails. One trial description for example starts with the sentence: “Chronic fatigue syndrome (CFS), also known as idiopathic chronic fatigue (ICF)…” To be upfront, we have the impression that quite a few of these researchers mistake ME/CFS for unexplained tiredness of a less severe nature.
Lastly, there are trials on behavioral interventions such as the MAGENTA and FITNET-NHS studies led by Esther Crawley in the UK. Apparently, there are still a few researchers who hold high hopes of changing patients’ thoughts and behavior as a treatment for ME/CFS, despite the failures of the past. There are registered ME/CFS trials on self-paced exercise, video gaming, computerized cognitive training, relaxation methods, biofeedback therapy, and so on.
A rather bleak conclusion
We can’t avoid the conclusion that the results of our search were rather bleak and disappointing. There are few decent clinical trials for ME/CFS that provide hope that a treatment will be found anytime soon. The nature of discovery, however, is that it comes unexpectedly. We hope this overview doesn’t promote pessimistic nihilism, but that it encourages increased efforts to rapidly expand the level of funding for ME/CFS research.
Michiel and Evelien